Senior Clinical Evidence Specialist
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IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
Basic Qualifications
• Bachelor’s Degree (biomedical or scientific)
• 5+ years of experience in clinical research and/or medical device surveillance and/or clinical evaluations
• Medical writing experience
• Project management experience
Desired/Preferred Qualifications
• Masters or PhD degree(s) in biomedical sciences or technical disciplines
• Direct experience with medical and/or scientific writing within a medical device industry or related industry
• Proficient knowledge of physiology and/or applicable disease states, medical terminology, CRHF therapies and technologies
• Proficient in Microsoft Office suite of products (e.g., MS Word and Excel)
• Proficient understanding of study design concepts
• Demonstrated ability to incorporate and adhere to regulatory standards
• Experience planning and executing internet literature searches using databases such as PubMed
• Effective organizational, communication, and project team skills; high attention to detail and accuracy
• Ability to work independently (content originator) and collaboratively (content review among stakeholders)
• Ability to translate engineering and marketing data into a device performance context
• Familiarity with international regulatory requirements and knowledge of relevant standards (e.g. ISO 14155, ISO 14971, MedDev 2.7.1 rev 4)
• Working knowledge of various writing style guidelines (e.g. AMA) and current publication practices and guidelines (ICMJE)
• Working knowledge of biostatistics
• Demonstrated ability to effectively interact with internal and external stakeholders
• Demonstrated ability to apply analytical skills to effectively summarize, communicate and present clinical trial outcomes
• Demonstrated ability to achieve objectives and milestones through identification and implementation of work plans and measurements
• Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; clear and concise writing style
• Demonstrated ability to identify and adapt to shifting priorities and competing demands for multiple projects and deadlines
• Demonstrated ability to maintain composure in difficult circumstances
• Demonstrated ability to identify and overcome obstacles
• Ability to constructively respond to feedback from customers and coworkers; team player
• Demonstrated ability to work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
• Experience working with Quosa, Endnote or other literature repository and citation management tools
Physical Job Requirements
• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
• Ability to travel up to 10%
MEDTRONIC OVERVIEW:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We can accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
